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Sponsors and Collaborators: |
Duke University National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00626483 |
RATIONALE: Monoclonal antibodies, such as daclizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Vaccines may help the body build an effective immune response to kill tumor cells. Giving these treatments together may kill more tumor cells.
PURPOSE: This clinical trial is studying how well daclizumab works in treating patients with newly diagnosed glioblastoma multiforme and temozolomide-caused lymphopenia who are undergoing targeted immunotherapy.
Condition | Intervention |
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Brain and Central Nervous System Tumors |
Drug: RNA-loaded dendritic cell vaccine Drug: cytomegalovirus pp65-specific cytotoxic T lymphocytes Drug: daclizumab Drug: imiquimod Drug: temozolomide Drug: therapeutic autologous dendritic cells Drug: therapeutic autologous lymphocytes Procedure: radionuclide imaging Procedure: single photon emission computed tomography Procedure: stereotactic radiation therapy |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | REGULATory T-Cell Inhibition With Daclizumab (Zenapax®) During Recovery From Therapeutic Temozolomide-Induced Lymphopenia During Antitumor Immunotherapy Targeted Against Cytomegalovirus in Patients With Newly-Diagnosed Glioblastoma Multiforme [REGULATe] |
Estimated Enrollment: | 6 |
Study Start Date: | March 2007 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients undergo leukapheresis for generation of dendritic cells (DCs) and autolymphocyte therapy (ALT) within 4 weeks after resection. After initial leukapheresis, all patients undergo stereotactic radiotherapy (RT) on days 1-5 and concurrent temozolomide (TMZ) IV on days 1-7 for 6.5 weeks in the absence of disease progression or unacceptable toxicity.
Beginning 3 weeks after completion of RT, patients receive TMZ IV on days 1-5. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Beginning on day 21 of the first course of TMZ, patients receive pp65-LAMP mRNA-loaded mature DCs every 2 weeks for 3 vaccinations. Concurrently with the first DC vaccination, patients receive ALT IV over 15 minutes and daclizumab IV over 15 minutes.
On day 21 of the second course of post-radiation TMZ, patients receive indium In 111-labeled DCs (fourth vaccination) and randomly assigned skin preparations (unpulsed DCs vs imiquimod cream applied to the vaccination site 6-24 hours before vaccination). Single-photon emission computed tomography (SPECT) images are used to quantitate migration to the inguinal lymph nodes.
After completion of study treatment, patients are followed every 2 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histopathologically confirmed glioblastoma multiforme
Residual radiographic contrast enhancement on post-resection CT scan or MRI must not exceed 1 cm in diameter in two perpendicular axial planes
PATIENT CHARACTERISTICS:
No allergy to temozolomide (TMZ) or otherwise unable to tolerate TMZ for reasons other than lymphopenia
PRIOR CONCURRENT THERAPY:
No concurrent corticosteroids, with the exception of nasal or inhaled steroids, at a dose above physiologic levels
United States, North Carolina | |
Duke Comprehensive Cancer Center | |
Durham, North Carolina, United States, 27710 |
Study Chair: | Duane Mitchell, MD, PhD | Duke University |
Study ID Numbers: | CDR0000579683, DUMC-PRO00000581, SPORE Project 3 |
Study First Received: | February 28, 2008 |
Last Updated: | December 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00626483 |
Health Authority: | United States: Food and Drug Administration |
adult giant cell glioblastoma adult gliosarcoma |
Glioblastoma Astrocytoma Hematologic Diseases Daclizumab Lymphopenia Imiquimod Leukocyte Disorders Central Nervous System Neoplasms Temozolomide Cytomegalovirus Immunologic Deficiency Syndromes |
Neuroectodermal Tumors Glioblastoma multiforme Neoplasms, Germ Cell and Embryonal Neuroepithelioma Cytomegalovirus Infections Glioma Gliosarcoma Leukopenia Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Immunologic Factors Immune System Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Neoplasms, Nerve Tissue Nervous System Diseases |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Antineoplastic Agents, Alkylating Neoplasms, Neuroepithelial Alkylating Agents |